加拿大卫生部：MDEL与MDL解析

What does Health Canada license? Two things: the businesses that import or sell medical devices in Canada, and the higher-risk devices themselves. Here is who needs which licence. First, the business. Importers and distributors need a Medical Device Establishment Licence, or MDEL, and so do Class I manufacturers, unless they distribute only through an MDEL holder. Retailers, health care facilities and manufacturers of Class II to IV devices are exempt. Then the device. Health Canada sorts devices into four risk classes, from Class I, the lowest, to Class IV, the highest. Three of the four, Classes II, III and IV, need a Medical Device Licence, held by the manufacturer. The business licence needs a review every year. For 2026 to 2027, the MDEL fee is 5,519 Canadian dollars, and the annual review is due before April 1. Start with three things. One: classify each device with the Schedule 1 rules. Two: get ISO 13485 certification for Class II to IV. Three: renew before April 1 and November 1. Know which licence you need. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.